Significant biosimilar activities this fortnight include
05 Feb 20 | Merck announced a new spin-off company which will incorporate products from its Women’s Health, Legacy Brands and Biosimilars businesses. The company is yet to be named but will be independent and publicly traded with the transaction expected to be completed in Q1/2 2021.
03 Feb 20 | The FDA released draft guidance on promotional labelling and advertising for biosimilars, inviting comments from industry until 2 April 2020.
03 Feb 20 | Bio-Thera announced the results for biosimilar BAT1706 (bevacizumab candidate) including that BAT1706 met the primary endpoint in PhIII clinical trials.
03 Feb 20 | The US FDA and FTC announced joint efforts to facilitate update of biosimilars, and deter anti-competitive behaviour in the biopharma industry.
31 Jan 20 | Pfizer announced it had received a positive CHMP opinion for Ruxience® (biosimilar rituximab) in EU.
27 Jan 20 | Health Canada approved ulcerative colitis as an additional indication for Stelara® (ustekinumab).